# FDA recall Z-0779-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-12-22.

## Product

JAGTOME RX 49-30-450-035    Material Number: M00573030

## Reason for recall

Sterility of device is compromised due to a sterile barrier breach

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco,  Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland,  Unit. Arab Emir.

## Key facts

- **Recall number:** Z-0779-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-22
- **Report date:** 2022-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0779-2022

## Citation

> AI Analytics. FDA recall Z-0779-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0779-2022. Source: US FDA. Licensed CC0.

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